NCT02485925已完成4 期
The Effectiveness and Safety in the Treatment of Circumferential Pulmonary Vein Isolation (CPVI) for Symptomatic Paroxysmal Atrial Fibrillation With THERMOCOOL® SMARTTOUCH™ Catheter in China, A Multi-center Clinical Registry Study
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- Percentage of Patients With Freedom From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes
研究概览
简要总结
This is a prospective effectiveness and safety assessment of the study device during radiofrequency (RF) ablation treatment of patients with drug refractory symptomatic atrial fibrillation.
详细描述
The purpose of this study is to assess the effectiveness and safety of the THERMOCOOL® SMARTTOUCH™ catheter in the treatment of drug refractory symptomatic paroxysmal atrial fibrillation (PAF) undergoing CPVI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Failure of at least one antiarrhythmic drug (AAD) for AF (class I or III, or AV nodal blocking agents such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic AF, or intolerance to the AAD
- •Patients with paroxysmal AF eligible for catheter ablation
- •Patients with symptomatic PAF who have had at least one documented AF episode in the twelve (12) months prior to enrollment. Documentation may include but is not limited to electrocardiogram (ECG), Holter monitor (HM) or transtelephonic monitor (TTM)
- •Able and willing to comply with all pre-, post- and follow-up testing and requirements
- •Be able to sign IRB/EC-approved informed consent form
排除标准
- •AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- •Previous surgical or catheter ablation for AF
- •Any PCI, cardiac surgery, or valvular cardiac surgical or percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repart or replacement and presence of a prosthetic valve) within the past 2 months.
- •Any carotid stenting or endarterectomy.
- •Coronary artery bypass graft (CABG) procedure within the last 180 days (6 months)
- •AF episodes lasting longer than 7 days or terminated via cardioversion
- •Documented left atrial thrombus on imaging
- •Uncontrolled heart Failure or New York Heart Association (NYHA) class III or IV
- •Myocardial Infarction within the previous 60 days (2 months)
- •Documented thromboembolic event (including TIA) within the past 12 months
- •Rheumatic heart disease
- •Awaiting cardiac transplantation or other cardiac surgery within the next 365 days (12 months)
- •Significant pulmonary disease, (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.
- •Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
- •Active illness or active systemic infection or sepsis
- •Diagnosed atrial myxoma
- •Unstable angina within the past 60 days (2 months)
- •History of blood clotting or bleeding abnormalities
- •Life expectancy less than 365 days (12 months)
- •Hypertrophic obstructive cardiomyopathy
- •Presence of implanted ICD
- •Contraindication to anticoagulation
- •Contraindication to isoproterenol
- •Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation
- •Women who are pregnant and/or breast feeding
- •Presence of a condition that precludes vascular access.
- •Patients presenting contraindications for study catheter(s), as indicated in the respective Instructions For Use
- •Enrollment in an investigational study evaluating another device, biologic, or drug.
研究组 & 干预措施
Treatment group
Experimental
THERMOCOOL® SMARTTOUCH™
干预措施: THERMOCOOL® SMARTTOUCH™ (Device)
结局指标
主要结局
Percentage of Patients With Freedom From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes
时间窗: 12 Months
The primary effectiveness endpoint for this study is freedom from documented symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 12-month follow-up after the index ablation procedure (includes a three-month blanking period).
次要结局
- Percentage of Patients Where Acute Success Was Achieved(0.5 hours)
- Average Contact Force Per Pulmonary Vein Ablation Procedure(1 day during procedure)
- Percent of Subjects With Pulmonary Vein Reconnection for the Index Procedure(1 day during procedure)
- Procedure Time, Ablation Time and Fluoroscopy Time(1 day during procedure)
研究者
相似试验
已完成
不适用
Clinical Study To Assess The Safety, Parameters And Efficacy For Procedures Using A Radiofrequency DeviceTissue HeatingCoagulationNCT05166824Cynosure, Inc.89
已完成
不适用
Efficacy and Safety Evaluation of Changes in Lower Extremity Edema of RadiofrequencyIdiopathic EdemaNCT05185193Pusan National University Yangsan Hospital15
Unknown
不适用
The Clinical Research of the Safety and Effectiveness Evaluation for Using Echocardiography-guided Liwen RF Radiofrequency Ablation System to Treat Hypertrophic Obstructive CardiomyopathyHypertrophic Obstructive CardiomyopathyNCT04355260Xijing Hospital150
尚未招募
不适用
A Prospective Clinical Study on the Safety and Efficacy of Radiofrequency Ablation for the Treatment of Patients With Desmoid TumorsDesmoid TumorDesmoid FibromatosisDesmoidNCT06355921Blokhin's Russian Cancer Research Center27
Unknown
不适用
Radiofrequency Ablation of Malignant Pulmonary NodulesNeoplasmsCarcinomaNCT02629978Chinese PLA General Hospital500